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4K Color Display

by Foreseeson Custom Displays Inc. 7 variants

Ref FM-F3101DG

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081000089059YN Basic UDI-DI 00810000890590UDI-DIDate26 Aug 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00810000890590 UDI-DI Date12 Mar 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
4K Color Display EUDAMED
Fsn GUDID
Generic Name
Image display unit, colour
Model / Ref / Catalog
FM-F3101DG, FM-F3101D
Primary DI / UDI-DI
00810000890590
Basic UDI-DI
081000089059YN
FDA Product Code
KQM
EMDN Code
Z11900802 Bioimaging viewing monitors
GMDN Term
Image display unit, colour
Device Class
Class I
Regulation Number
878.4160
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FM-F3101DG
GUDID
FM-F3101D, FM-F3101DG

Manufacturer details

EUDAMED SRN
US-MF-000012443
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Foreseeson Custom Displays, Inc.

See all devices from Foreseeson Custom Displays, Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No